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Etude évaluant l’imagerie proche infrarouge couplée au vert d’indocyanine pour le contrôle peropératoire des marges de résection en chirurgie ORL (MAGNOLIA)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502737-26-00
Enrollment
65
Registered
2023-03-06
Start date
2020-12-15
Completion date
Unknown
Last updated
2025-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

epidermoid carcinoma

Brief summary

Sensitivity of real-time near-infrared fluorescence imaging in the first and last sections in which pathological examination confirms the presence of microscopic residual disease after complete gross surgical resection.

Detailed description

Specificity of real-time near-infrared fluorescence imaging to detect healthy margins in real time. - Positive predictive value of real-time near-infrared fluorescence imaging to detect microscopic residual disease in the surgical bed after resection. - Tumor to background ratio (TBR) mapping and kinetics - Number of patients with adverse events and their grade to measure safety and tolerability

Interventions

Sponsors

Institut Gustave Roussy
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Sensitivity of real-time near-infrared fluorescence imaging in the first and last sections in which pathological examination confirms the presence of microscopic residual disease after complete gross surgical resection.

Secondary

MeasureTime frame
Specificity of real-time near-infrared fluorescence imaging to detect healthy margins in real time. - Positive predictive value of real-time near-infrared fluorescence imaging to detect microscopic residual disease in the surgical bed after resection. - Tumor to background ratio (TBR) mapping and kinetics - Number of patients with adverse events and their grade to measure safety and tolerability

Countries

Belgium, France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026